IBDSUSINCT01551563
Stavanger University Hospital Inflammatory Bowel Disease Trial
An observational study of IBD, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- IBD
- How many people
- 700 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2012to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All newly diagnosed IBD patients (Crohns and Ulcerative colitis) within Stavanger Univ Hospital catchment area
Who may be able to join
- newly diagnosed IBD
Who cannot join
- previous IBD with specific treatment within 10 year
- inability to consent
- inability to adhere to treatment protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
tore grimstad contact
lars aabakken contact
Norway1 site, 1 recruiting
- Recruiting
SUS
Stavanger
Tore B Grimstad, MD PhD, +47909 21 650
About this study
Official title: Management of Inflammatory Bowel Disease in the Stavanger Area - a Prospective Evaluation of Standardized Treatment Regimens on Disease Outcome With Focus on Mucosal Healing and Associations to Fatigue
The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined.
Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.
Read the detailed description
none considered needed
- Conditions
- IBD
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of IBD drug therapy
Endoscopic, clinical and biochemical response
Measured: 5 years
Secondary outcomes (3)
Fatigue in patients with coeliac disease - substudy
Fatigue severity and prevalence at diagnosis and after one year of gluten free diet
Measured: 1 year
Fatigue in IBD
Fatigue severity and prevalence at diagnosis and during follow-up
Measured: 5 years
IBD and the intestinal microbiome
Microbiome/eukaryome profiles associated with disease activity and treatment response from diagnosis and during follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tore Grimstad, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551563
- Sponsor's protocol ID
- SUSI_1
- Acronym
- SUSI
- Status last verified
- May 2025
- First submitted
- 8 Mar 2012
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Skjellerudsveen BM, Omdal R, Hetta AK, Kvaloy JT, Aabakken L, Skoie IM, Grimstad T. Less, but not gone-gluten-free diet effects on fatigue in celiac disease: a prospective controlled study. Front Med (Lausanne). 2023 Sep 12;10:1242512. doi: 10.3389/fmed.2023.1242512. eCollection 2023.
PubMed 37766922Grimstad T, Skoie IM, Doerner J, Isaksen K, Karlsen L, Aabakken L, Omdal R, Putterman C. TWEAK is not elevated in patients with newly diagnosed inflammatory bowel disease. Scand J Gastroenterol. 2017 Apr;52(4):420-424. doi: 10.1080/00365521.2016.1273382. Epub 2016 Dec 31.
PubMed 28040992Grimstad T, Norheim KB, Isaksen K, Leitao K, Hetta AK, Carlsen A, Karlsen LN, Skoie IM, Goransson L, Harboe E, Aabakken L, Omdal R. Fatigue in Newly Diagnosed Inflammatory Bowel Disease. J Crohns Colitis. 2015 Sep;9(9):725-30. doi: 10.1093/ecco-jcc/jjv091. Epub 2015 May 19.
PubMed 25994356
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Inflammatory Bowel Disease in the Stavanger Area - a Prospective Evaluation of Standardized Treatment Regimens on Disease Outcome With Focus on Mucosal Healing and Associations to Fatigue
- ClinicalTrials.gov ID
- NCT01551563
- Acronym / sponsor ID
- SUSI / SUSI_1
- Conditions
- IBD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Apr 2012
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined.
Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.
Detailed description
none considered needed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All newly diagnosed IBD patients (Crohns and Ulcerative colitis) within Stavanger Univ Hospital catchment area
Key inclusion criteria (1 listed)
- newly diagnosed IBD
Key exclusion criteria (3 listed)
- previous IBD with specific treatment within 10 year
- inability to consent
- inability to adhere to treatment protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical efficacy of IBD drug therapy
Time frame: 5 years
Endoscopic, clinical and biochemical response
3 secondary outcomes
Fatigue in patients with coeliac disease - substudy
Time frame: 1 year
Fatigue in IBD
Time frame: 5 years
IBD and the intestinal microbiome
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 37766922Skjellerudsveen BM, Omdal R, Hetta AK, Kvaloy JT, Aabakken L, Skoie IM, Grimstad T. Less, but not gone-gluten-free diet effects on fatigue in celiac disease: a prospective controlled study. Front Med (Lausanne). 2023 Sep 12;10:1242512. doi: 10.3389/fmed.2023.1242512. eCollection 2023.
- Derived from this study: PubMed 28040992Grimstad T, Skoie IM, Doerner J, Isaksen K, Karlsen L, Aabakken L, Omdal R, Putterman C. TWEAK is not elevated in patients with newly diagnosed inflammatory bowel disease. Scand J Gastroenterol. 2017 Apr;52(4):420-424. doi: 10.1080/00365521.2016.1273382. Epub 2016 Dec 31.
- Derived from this study: PubMed 25994356Grimstad T, Norheim KB, Isaksen K, Leitao K, Hetta AK, Carlsen A, Karlsen LN, Skoie IM, Goransson L, Harboe E, Aabakken L, Omdal R. Fatigue in Newly Diagnosed Inflammatory Bowel Disease. J Crohns Colitis. 2015 Sep;9(9):725-30. doi: 10.1093/ecco-jcc/jjv091. Epub 2015 May 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
tore grimstad contact
lars aabakken contact
Tore Grimstad, PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact tore grimstad (tore.bjorn.grimstad@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy of IBD drug therapy (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551563, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.